Maintenance Technician

4 days ago


Union Valley, Texas, United States Elgen Staffing Full time
Job Summary

We are seeking an experienced Maintenance Mechanic to join our team at Elgen Staffing. As a key member of our manufacturing team, you will be responsible for supporting the overall GMP Fill Finish manufacturing processes, ensuring the highest quality standards are met.

Key Responsibilities
  • Support and maintain aseptic qualification training
  • Collaborate with internal teams to meet site goals and objectives
  • Adhere to all environmental, health, and safety policies and procedures
  • Perform routine and enhanced cleaning and sanitization of all controlled aseptic cleanrooms
  • Transport equipment and components as needed
  • Interact with filling machines at validated speeds and volumes
  • Perform volume checks and document inherent and non-inherent interventions
  • Ensure slow and purposeful movements in a Grade A/B GMP aseptic environment
  • Work with R&D and tech transfer team for successful transfer of programs into the GMP area
  • Perform pre- and post-filter integrity testing as required
  • Aseptically sterile filter products into appropriate vessels
Requirements
  • High school diploma or equivalent with 5+ years' experience or Bachelor's degree with a minimum of 3 years of experience
  • Prior experience in related field, preferred
  • Demonstrate the ability to work well in a cross-functional team environment
  • Basic math skills
  • cGMP manufacturing knowledge, preferred
  • Aseptic filling and general production knowledge, preferred
  • Knowledge / Experience with electronic Quality Management Systems such as MasterControl
  • Must be able to comprehend and follow all applicable SOPs
  • Demonstrated ability to execute a task, unit operation and/or document (forms and/or SOPs) with little to no assistance
  • Knowledge of current federal, local, and international regulations regarding the production, testing and release of drug substances and products
  • Demonstrate familiarity with Microsoft programs like Word, Excel, Teams and Outlook
  • Demonstrate the ability to portray the appropriate level of integrity and professionalism
  • Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats
  • Demonstrate the ability to complete tasks accurately and according to established and shifting timelines
  • Demonstrate the ability to make quality scheduling, resource allocation, and managing priorities

Please apply today to be considered for this role


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